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HIV/AIDS Therapy

Company updates development of fixed-dose regimen of Truvada and Sustiva

Published in Drug Week, September 9th, 2005

Gilead Sciences, Inc., (GILD) announced that bioequivalence results from its second formulation of the fixed-dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Bristol-Myers Squibb's Sustiva (efavirenz) for the treatment of HIV did not demonstrate bioequivalence to the individual products dosed separately.

The company is proceeding with the evaluation of up to three new formulations, developed based on bilayer technology. This bilayer technology involves coformulation of Truvada and Sustiva as individually formulated layers combined together in one tablet. Gilead will initiate the bioequivalence studies in humans and stability studies of...

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